lamivudine/tenofovir DF (Rx)

Brand and Other Names:Cimduo, Temixys
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

lamivudine/tenofovir DF (ie, tenofovir disoproxil fumarate)

tablet

  • 300mg/300mg

HIV Infection

Indicated in combination with other antiretroviral agents for HIV-1 infection

1 tablet (lamivudine 300 mg/tenofovir 300 mg) PO qDay in combination with other ARTs

Also see Administration

Dosage Modifications

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment necessary
  • Moderate-to-severe (Child-Pugh B or C): Not recommended

Renal impairment

  • CrCl ≥50 mL/min: No dosage adjustment necessary
  • CrCl <50 mL/min or end-stage renal disease (ESRD) requiring hemodialysis: Not recommended because drug is a fixed-dose combination tablet and dose cannot be adjusted

Dosing Considerations

Testing prior to initiation and during treatment

  • Prior to initiation of lamivudine/tenofovir DF, test patients for hepatitis B virus (HBV)
  • Assess serum creatinine, serum phosphorus, estimated CrCl, urine glucose, and urine protein in all patients as clinically appropriate
  • Monitor hepatic function

Dosage Forms & Strengths

lamivudine/tenofovir DF (ie, tenofovir disoproxil fumarate)

tablet

  • 300mg/300mg

HIV Infection

Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adults weighing >35 kg

Combination consists of 2 nucleo(t)side reverse transcriptase inhibitors (NRTIs) (ie, lamivudine and tenofovir)

1 tablet (lamivudine 300 mg/tenofovir 300 mg) PO qDay in combination with other ARTs

Also see administration

Dosage Modifications

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment necessary
  • Moderate-to-severe (Child-Pugh B or C): Not recommended

Renal impairment

  • CrCl ≥50 mL/min: No dosage adjustment necessary
  • CrCl <50 mL/min or end-stage renal disease (ESRD) requiring hemodialysis: Not recommended because drug is a fixed-dose combination tablet and dose cannot be adjusted

Dosing Considerations

Testing prior to initiation and during treatment

  • Prior to initiation of lamivudine/tenofovir DF, test patients for hepatitis B virus (HBV)
  • Assess serum creatinine, serum phosphorus, estimated creatinine clearance, urine glucose, and urine protein in all patients as clinically appropriate
  • Monitor hepatic function

Clinical trials did not include sufficient number of patients aged ≥65 yr to determine if they respond differently from younger individuals

Exercise caution when administering lamivudine in elderly patients because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy

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Interactions

Interaction Checker

and lamivudine/tenofovir DF

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (2)

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              lamivudine, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.

            • emtricitabine

              emtricitabine and lamivudine both increase risk of immune reconstitution syndrome. Contraindicated. Coadministration of emtricitabine containing products and lamivudine containing products should be avoided. Combination will result in therapeutic duplication.

              emtricitabine, lamivudine. Other (see comment). Contraindicated. Comment: Coadministration of emtricitabine containing products and lamivudine containing products should be avoided. Combination will result in therapeutic duplication.

            Serious - Use Alternative (4)

            • cabotegravir

              lamivudine, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.

            • sorbitol

              sorbitol will decrease the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Sorbitol-containing solution decreased systemic exposure of lamivudine oral solution in a pediatric study (ARROW trial). Results showed lower rates of virologic suppression, lower plasma lamivudine exposure, and development of viral resistance more frequently than children receiving lamivudine tablets.

            • tafenoquine

              tafenoquine will increase the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Tafenoquine inhibits organic cation transporter-2 (OCT2) and multidrug and toxin extrusion (MATE) transporters in vitro. Avoid coadministration with OCT2 or MATE substrates. If coadministration cannot be avoided, monitor for substrate-related toxicities and consider dosage reduction if needed based on product labeling of the coadministered drug.

            • trilaciclib

              trilaciclib will decrease the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with substrates where minimal increased concentration in kidney or blood may lead to serious or life-threatening toxicities.

            Monitor Closely (24)

            • abacavir

              abacavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • atazanavir

              atazanavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • cabozantinib

              lamivudine will increase the level or effect of cabozantinib by Other (see comment). Use Caution/Monitor. MRP2 inhibitors increase cabozantinib toxicity

            • efavirenz

              efavirenz and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • enfuvirtide

              enfuvirtide and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • erdafitinib

              lamivudine increases levels of erdafitinib by decreasing renal clearance. Modify Therapy/Monitor Closely. Consider alternatives that are not OCT2 substrates or consider reducing the dose of OCT2 substrates based on tolerability.

            • fosamprenavir

              fosamprenavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • ganciclovir

              ganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Increased risk of hematologic toxicity.

            • indinavir

              indinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • interferon alfa 2b

              interferon alfa 2b, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.

            • nelfinavir

              nelfinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • nevirapine

              lamivudine and nevirapine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • orlistat

              orlistat will decrease the level or effect of lamivudine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

            • peginterferon alfa 2a

              peginterferon alfa 2a, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.

            • peginterferon alfa 2b

              peginterferon alfa 2b, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.

            • ribavirin

              ribavirin increases toxicity of lamivudine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of lactic acidosis.

            • ritonavir

              ritonavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • saquinavir

              saquinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • stavudine

              lamivudine and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • tenofovir DF

              lamivudine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • tipranavir

              tipranavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • trimethoprim

              trimethoprim increases effects of lamivudine by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor. Potential for increased toxicity.

            • valganciclovir

              valganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.

            • zidovudine

              lamivudine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            Minor (3)

            • isavuconazonium sulfate

              isavuconazonium sulfate will increase the level or effect of lamivudine by Other (see comment). Minor/Significance Unknown. Isavuconazonium sulfate, an OCT2 inhibitor, may increase the effects or levels of OCT2 substrates.

            • sulfamethoxazole

              sulfamethoxazole increases levels of lamivudine by decreasing renal clearance. Minor/Significance Unknown.

            • zidovudine

              lamivudine increases effects of zidovudine by pharmacodynamic synergism. Minor/Significance Unknown. Beneficial synergism.

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            Adverse Effects

            Listed adverse reactions are Grade 2-4 unless specified

            >10%

            Rash (18%)

            Headache (14%)

            Pain (13%)

            Diarrhea (11%)

            Depression (11%)

            Grade 3-4 laboratory abnormalities

            • Fasting cholesterol >250 mg/dL (19%)
            • Creatine kinase (males: >990 U/L; females >845 U/L) (12%)

            1-10%

            Back pain (9%)

            Fever (8%)

            Abdominal pain (7%)

            Asthenia (6%)

            Anxiety (6%)

            Arthralgia (5%)

            Insomnia (5%)

            Pneumonia (5%)

            Myalgia (3%)

            Dizziness (3%)

            Lipodystrophy (1%)

            Peripheral neuropathy (1%)

            Grade 3-4 laboratory abnormalities

            • Serum amylase >175 U/L (9%)
            • Hematuria >100 RBC/HPF (7%)
            • AST elevated (5%)
            • ALT elevated (4%)
            • Neutrophils <750 mg/dL (3%)
            • Fasting triglycerides >750 mg/dL (1%)

            Postmarketing Reports

            Lamivudine

            • Body as a whole: Redistribution/accumulation of body fat
            • Endocrine and metabolic: Hyperglycemia
            • General: Weakness
            • Hemic and lymphatic: Anemia (including pure red blood cell aplasia and severe anemias progressing on therapy)
            • Hepatic and pancreatic: Lactic acidosis and hepatic steatosis, posttreatment exacerbation of hepatitis B
            • Hypersensitivity: Anaphylaxis, urticaria
            • Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis
            • Skin: Alopecia, pruritus

            Tenofovir DF

            • Immune system disorders: Allergic reaction, including angioedema
            • Metabolism and nutrition disorders: Lactic acidosis, hypokalemia, hypophosphatemia
            • Respiratory, thoracic, and mediastinal disorders: Dyspnea
            • Gastrointestinal disorders: Pancreatitis, increased amylase, abdominal pain
            • Renal and urinary disorders: Renal insufficiency, acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria
            • Hepatobiliary disorders: Hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)
            • Skin and subcutaneous tissue disorders: Rash
            • Musculoskeletal and connective-tissue disorders: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
            • General disorders and administration site conditions: Asthenia
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            Warnings

            Black Box Warnings

            Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 and who have discontinued lamivudine or tenofovir DF

            Closely monitor hepatic function in these patients and initiate antihepatitis B treatment if necessary

            Contraindications

            Documented hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions) to any components contained in the formulation

            Cautions

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analogs and other ARTs; suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity

            Clinical trials in HIV-infected subjects demonstrated regimens contained only 3 NRTIs are generally less effective than triple drug regimens containing 2 NRTIs in combination with either a non-nucleoside reverse transcriptase inhibitor or a HIV-1 protease inhibitor; early virological failure and high rates of resistance substitutions reported; use triple NRTI regimens with caution; carefully monitor patients on a therapy utilizing a triple nucleoside-only regimen and consider for treatment modification

            Not approved for chronic hepatitis B virus (HBV) infection and safety and efficacy not established in patients coinfected with HBV and HIV-1; if treatment with Epivir-HBV, tenofovir DF, or a tenofovir AF-containing product is prescribed for chronic hepatitis B for a patient with unrecognized or untreated HIV-1 infection, rapid emergence of HIV-1 resistance is likely to result because of subtherapeutic dose and the inappropriateness of monotherapy HIV-1 treatment (see Black Box Warnings and Dosing Considerations)

            Immune reconstitution syndrome reported in HIV-infected patients treated with combination ART; during initial phase of combination ART, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), tuberculosis), and further evaluation and treatment may be necessary

            Autoimmune disorders (eg, Grave disease, polymyositis, and Guillain-Barré syndrome) reported to occur in the immune reconstitution setting; however, time to onset varies and can occur many months after initiation of treatment

            In HIV-infected patients, redistribution/accumulation of body fat (eg, central obesity, dorsocervical fat enlargement [buffalo hump], peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance) observed in patients receiving combination ART

            In pediatric patients with a history of prior antiretroviral nucleoside exposure, a history of pancreatitis, or other significant risk factors for the development of pancreatitis, lamivudine should be used with caution

            Bone effects of tenofovir

            • In clinical trials, tenofovir DF was associated with slightly greater decreases in bone mineral density and increases in biochemical markers of bone metabolism
            • Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, reported
            • Persistent or worsening bone pain, pain in extremities, fractures, and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in at-risk patients
            • Effects of tenofovir DF-associated changes in BMD and biochemical markers on long-term bone health and future fracture risk in adults and pediatric subjects 2 years and older are unknown
            • Long-term effect of lower spine and total body BMD on skeletal growth in pediatric patients, and in particular, effects of long-duration exposure in younger children unknown
            • Consider assessment of BMD for adult and pediatric patients who have history of pathologic bone fracture or other risk factors for osteoporosis or bone loss; if bone abnormalities are suspected obtain appropriate consultation

            New onset or worsening renal impairment

            • Renal impairment (eg, acute renal failure, Fanconi syndrome) reported with the use of tenofovir DF
            • Prior to initiation and during therapy, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients; in patients with chronic kidney disease, also assess serum phosphorus
            • Cases of acute renal failure after initiation of high-dose or multiple nonsteroidal anti-inflammatory drugs (NSAIDs) reported in HIV-infected patients with risk factors for renal dysfunction who appeared stable on tenofovir DF; some patients required hospitalization and renal replacement therapy

            Drug interactions overview

            • Tenofovir DF decreases AUC and minimal plasma concentrations of atazanavir; do not administer tenofovir DF with atazanavir without ritonavir; coadministration with drug combinations (eg, lopinavir/ritonavir, atazanavir and ritonavir, darunavir and ritonavir) may increase tenofovir concentrations; monitor for tenofovir-associated adverse reactions; discontinue treatment in patients who develop tenofovir-associated adverse reactions
            • Since tenofovir is primarily eliminated by the kidneys, coadministration of lamivudine/tenofovir DF with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir and/or increase the concentrations of other renally eliminated drugs; avoid lamivudine/tenofovir DF with concurrent or recent use of a nephrotoxic agent (eg, high-dose or multiple NSAIDs); consider alternatives to NSAIDs, if needed, in patients at risk for renal dysfunction
            • Lamivudine is predominantly eliminated in the urine by active organic cationic secretion; coadministration with drugs eliminated via organic cationic transport system (eg, trimethoprim) may interact with lamivudine
            • Coadministration of single doses of lamivudine and sorbitol resulted in a sorbitol dose-dependent reduction in lamivudine exposures; when possible, avoid use of sorbitol-containing medicines with lamivudine
            • Hepatic decompensation, some fatal, reported in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon and ribavirin-based regimens; monitor for treatment-associated toxicities; discontinue therapy, as medically appropriate, and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both
            • Hepatitis C antiviral agents
              • Coadministration of tenofovir DF with sofosbuvir/velpatasvir or ledipasvir/sofosbuvir has been shown to increase tenofovir exposure; monitor for adverse reactions associated with tenofovir DF
              • In patients receiving lamivudine/tenofovir DF concomitantly with ledipasvir/sofosbuvir with an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, consider an alternative
              • HCV or antiretroviral therapy, safety of increased tenofovir concentrations in this setting not established; if coadministration is necessary, monitor for adverse reactions associated with tenofovir
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            Pregnancy & Lactation

            Pregnancy

            An ART pregnancy registry has been established (1-800-258-4263); prospective pregnancy data from the Antiviral Pregnancy Registry (APR) not sufficient to adequately assess risk of birth defects or miscarriage

            Lamivudine produced embryonic toxicity in rabbits at a dose that produced similar human exposures as the recommended clinical dose; relevance of animal findings to human pregnancy registry data is not known; there are no adequate and well-controlled studies with tenofovir DF in pregnant women; tenofovir DF should be used during pregnancy only if clearly needed

            Lactation

            The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection

            Lamivudine is excreted into human milk

            Samples of breast milk obtained from five HIV-1-infected mothers in the first postpartum week show that tenofovir is excreted in human milk at low levels; impact of this exposure in breastfed infants is unknown and the effects of tenofovir DF on milk production is unknown

            Owing to the potential for HIV transmission (in HIV-negative infants), developing viral resistance (in HIV-positive infants), and adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Tenofovir: NRTI; following hydrolysis and phosphorylation, inhibits HIV-1 reverse transcriptase by competing with AMP as substrate

            Lamivudine: NRTI; following phosphorylation, inhibits HIV reverse transcriptase by viral DNA chain termination; cytosine analog

            Absorption

            Lamivudine

            • Peak plasma concentration: 1.5 mcg/mL (2 mg/kg BID)
            • Bioavailability: 86% (150-mg tablet); 87% (oral solution)
            • Peak plasma concentration
              • CrCl >60 mL/min, single 300-mg dose: 2.6 mcg/mL
              • CrCl 10-30 mL/min, single 300-mg dose: 3.6 mcg/mL
              • CrCl <10 mL/min, single 300-mg dose: 6 mcg/mL
            • AUC
              • CrCl >60 mL/min, single 300-mg dose: 11 mcg•hr/mL
              • CrCl 10-30 mL/min, single 300-mg dose: 48 mcg•hr/mL
              • CrCl <10 mL/min, single 300-mg dose: 157 mcg•hr/mL

            Tenofovir DF

            • Peak plasma time: 1 hr
            • Bioavailability: ~25% (fasted)
            • Peak plasma concentration
              • Fasted; single 300-mg dose: 296 ng/mL
              • CrCl >80 mL/min, single 300-mg dose: 0.34 mcg/mL
              • CrCl >80 mL/min, single 300-mg dose: 0.34 mcg/mL
              • CrCl 50-80 mL/min, single 300-mg dose: 0.33 mcg/mL
              • CrCl 30-49 mL/min, single 300-mg dose: 0.37 mcg/mL
              • CrCl 12-29 mL/min, single 300-mg dose: 0.6 mcg/mL
            • AUC
              • Fasted; single 300-mg dose: 2287 ng•hr/mL
              • CrCl >80 mL/min, single 300-mg dose: 2.18 mcg•hr/mL
              • CrCl 50-80 mL/min, single 300-mg dose: 3.06 mcg•hr/mL
              • CrCl 30-49 mL/min, single 300-mg dose: 6.01 mcg•hr/mL
              • CrCl 12-29 mL/min, single 300-mg dose: 15.98 mcg•hr/mL

            Distribution

            Lamivudine

            • Protein bound: <36%

            Tenofovir DF

            • Protein bound: <7% (0.01-25 mcg/mL)

            Metabolism

            Tenofovir DF: Not by CYP; converted intracellularly by hydrolysis to tenofovir, then phosphorylated to active tenofovir diphosphate

            Excretion

            Lamivudine

            • Excretion, trans-sulfoxide metabolite: Urine (5.2%)
            • Majority of lamivudine is eliminated unchanged in urine by active organic cationic secretion
            • Half-life: 5-7 hr

            Tenofovir DF

            • Excretion: Urine (~70-80% [unchanged drug])
            • Half-life: ~17 hr
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            Administration

            Oral Administration

            Oral use only

            Take one each day with or without food

            Missed dose

            • Missed dose: Take dose as soon as possible
            • If it is almost time for next dose, skip missed dose and take next dose at your regular time

            Storage

            Tablets: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

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            Patient Handout

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            Formulary

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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